Back to resultsClinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma
Primary Purpose
Liver Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
18F-RD2
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Carcinoma
Eligibility Criteria
Inclusion Criteria: Patients with highly suspected tumor； Patients underwent PET/CT examination within 1 week; Patients voluntarily signed informed consent; Over 18 years old, male or female. Exclusion Criteria: Pregnant women; Lactating women; Patients with impaired renal function.
Sites / Locations
- Affiliated Hospital of Jiangnan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-RD2
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of tissue distribution of 18F-RD2
Biodistribution of 18F-RD2 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-RD2 scans will be reported.
Secondary Outcome Measures
Full Information
NCT ID
NCT05681234
First Posted
December 27, 2022
Last Updated
December 27, 2022
Sponsor
Affiliated Hospital of Jiangnan University
1. Study Identification
Unique Protocol Identification Number
NCT05681234
Brief Title
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma
Official Title
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 24, 2022 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiangnan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single arm study to evaluate the safety and biodistribution of 18F-labeled RD2 PET/CT Imaging in patients with small liver carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F-RD2
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
18F-RD2
Intervention Description
Patients will receive 5-10 mCi 18F-RD2
Primary Outcome Measure Information:
Title
Evaluation of tissue distribution of 18F-RD2
Description
Biodistribution of 18F-RD2 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-RD2 scans will be reported.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with highly suspected tumor；
Patients underwent PET/CT examination within 1 week;
Patients voluntarily signed informed consent;
Over 18 years old, male or female.
Exclusion Criteria:
Pregnant women;
Lactating women;
Patients with impaired renal function.
Facility Information:
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Application of 18F-labeled RD2 PET/CT Imaging in the Diagnosis and Treatment of Small Liver Carcinoma
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